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TLX250-CDx (Zircaix) · 1 trial · 1 indication
Evaluating this outcome involved using a PET/CT machine on all patients to determine the uptake of the Zr89 radiotracer within the renal lesion, which was then compared to the histological determination of the lesion type following resection
| Arm | Type | Description |
|---|---|---|
| Experimental arm receiving the IP | EXPERIMENTAL | Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging. Following pre-screen morphological imaging to confirm evidence of IRM (to occur within 90 days of study enrolment), participants will attend a screening visit within 30 days of study enrolment, at which time baseline examinations will be undertaken. On Day 0, all successfully screened participants will undergo a slow IV administration of 89Zr- TLX250, at the nuclear medicine service of the respective study site. For all subjects, a PET/CT scan of the abdomen will occur on visit Day 5 (±2 days post administration \[p.a.\]) with nephrectomy to be performed any time after the PET/CT imaging visit, but no later than 90 days p.a. 89Zr-TLX250. |
| Name | Type | Description |
|---|---|---|
| 89Zr-TLX250 PET/CT | DRUG | 89Zr-TLX250, is a chimeric monoclonal antibody (INN name: girentuximab) with specificity for the CAIX (carbonic anhydrase 9) antigen, radiolabelled with the positron emitting radiometal zirconium- 89. Girentuximab has a CAS number of 916138-87-9. The chemical formula, without the 89Zr and the desferrioxamine, is C6460H1006N1718O2018S48 with a molecular mass of 146.5 kg/mol. 89Zr-TLX250 is formulated as a solution for IV administration in glass vials at the nominal dosage strength of 37 MBq (±10%) for single IV use. The mass dose of 89Zr-TLX250 to be used in this Phase 3 study will be 10 mg, labelled with 37 MBq (±10%) 89Zr per dose. |
Inclusion Criteria: 1. Written and voluntarily given informed consent. 2. Mainland Chinese male or female, aged ≥ 18 years. 3. Imaging evidence of a single IRM of ≤ 7 cm in largest diameter (tumour stage cT1), on SoC imaging based on national standards, not older than 90 days on Day 0, but performe...
TLX250-CDx, also called Zircaix, is an investigational PET/CT imaging agent being developed for clear cell renal cell carcinoma (ccRCC), the most common form of kidney cancer. It is a monoclonal antibody-based product from Telix Pharmaceuticals Limited and is currently in Phase 3 clinical development.
TLX250-CDx is being developed for PET/CT imaging of clear cell renal cell carcinoma. It is intended to help visualize ccRCC lesions during diagnostic imaging. The agent is investigational and is being evaluated in a Phase 3 study in China; it is not approved for commercial use.
TLX250-CDx is developed by Telix Pharmaceuticals Limited, which trades under the ticker TLX. Telix is the sponsor of the clinical program evaluating the imaging agent in clear cell renal cell carcinoma.
TLX250-CDx is in Phase 3 clinical development. It is an investigational imaging agent and has not been approved by the FDA. The ongoing Phase 3 study is currently recruiting participants.
TLX250-CDx is being evaluated in the ZIRCON-CP study, registered as NCT06750419, titled "89Zr-TLX250 for PET/CT Imaging of ccRCC." This Phase 3 trial is recruiting and plans to enroll 82 participants aged 18 years and older in China. It is an uncontrolled study.